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510(k) Data Aggregation

    K Number
    K023314
    Device Name
    MICROFIX
    Manufacturer
    FIXANO SA
    Date Cleared
    2002-10-18

    (45 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIXANO SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fixano MICROFIX device is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.
    Device Description
    The device is a radiolucent external fixator.
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    K Number
    K022771
    Device Name
    TWIN FIX
    Manufacturer
    FIXANO SA
    Date Cleared
    2002-09-23

    (33 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIXANO SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fixano TWIN FIX wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
    Device Description
    The device is a radiolucent external fixator capable of limited range of motion.
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    K Number
    K012062
    Device Name
    PF2
    Manufacturer
    FIXANO SA
    Date Cleared
    2001-09-27

    (87 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIXANO SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
    Device Description
    The device is a balljoint-hinged external fixator capable of rotation and anqulation.
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    K Number
    K012078
    Device Name
    RADIOFIX
    Manufacturer
    FIXANO SA
    Date Cleared
    2001-09-27

    (87 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIXANO SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.
    Device Description
    The device is a radiolucent external fixator capable of rotation and angulation.
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    K Number
    K012161
    Device Name
    FLEX-NAILS
    Manufacturer
    FIXANO SA
    Date Cleared
    2001-08-24

    (44 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIXANO SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.
    Device Description
    The device is a flexible titanium nail for orthopedic implantation.
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